Last reviewed 2026-04-22 · How we verify

BNX sublingual tablets

Orexo AB · Phase 3 active Small molecule

BNX sublingual tablets is a Partial mu-opioid receptor agonist Small molecule drug developed by Orexo AB. It is currently in Phase 3 development for Opioid use disorder maintenance treatment, Moderate to severe pain. Also known as: OX219, Zubsolv.

BNX is a buprenorphine sublingual tablet that binds to opioid receptors to provide analgesia and opioid dependence treatment.

BNX is a buprenorphine sublingual tablet that binds to opioid receptors to provide analgesia and opioid dependence treatment. Used for Opioid use disorder maintenance treatment, Moderate to severe pain.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	BNX sublingual tablets
Also known as	OX219, Zubsolv
Sponsor	Orexo AB
Drug class	Partial mu-opioid receptor agonist
Target	Mu-opioid receptor (OPRM1)
Modality	Small molecule
Therapeutic area	Pain Management / Addiction Medicine
Phase	Phase 3

Mechanism of action

Buprenorphine is a partial mu-opioid receptor agonist that produces analgesia and reduces cravings in opioid use disorder. As a sublingual formulation, it allows rapid absorption through the oral mucosa, bypassing first-pass hepatic metabolism. The partial agonist profile provides a ceiling effect on respiratory depression, making it safer than full opioid agonists.

Approved indications

Opioid use disorder maintenance treatment
Moderate to severe pain

Common side effects

Headache
Nausea
Constipation
Dizziness
Sweating
Insomnia

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

BNX sublingual tablets CI brief — competitive landscape report
BNX sublingual tablets updates RSS · CI watch RSS
Orexo AB portfolio CI

Frequently asked questions about BNX sublingual tablets

What is BNX sublingual tablets?

BNX sublingual tablets is a Partial mu-opioid receptor agonist drug developed by Orexo AB, indicated for Opioid use disorder maintenance treatment, Moderate to severe pain.

How does BNX sublingual tablets work?

BNX is a buprenorphine sublingual tablet that binds to opioid receptors to provide analgesia and opioid dependence treatment.

What is BNX sublingual tablets used for?

BNX sublingual tablets is indicated for Opioid use disorder maintenance treatment, Moderate to severe pain.

Who makes BNX sublingual tablets?

BNX sublingual tablets is developed by Orexo AB (see full Orexo AB pipeline at /company/orexo-ab).

Is BNX sublingual tablets also known as anything else?

BNX sublingual tablets is also known as OX219, Zubsolv.

What drug class is BNX sublingual tablets in?

BNX sublingual tablets belongs to the Partial mu-opioid receptor agonist class. See all Partial mu-opioid receptor agonist drugs at /class/partial-mu-opioid-receptor-agonist.

What development phase is BNX sublingual tablets in?

BNX sublingual tablets is in Phase 3.

What are the side effects of BNX sublingual tablets?

Common side effects of BNX sublingual tablets include Headache, Nausea, Constipation, Dizziness, Sweating, Insomnia.

What does BNX sublingual tablets target?

BNX sublingual tablets targets Mu-opioid receptor (OPRM1) and is a Partial mu-opioid receptor agonist.

Drug class: All Partial mu-opioid receptor agonist drugs
Target: All drugs targeting Mu-opioid receptor (OPRM1)
Manufacturer: Orexo AB — full pipeline
Therapeutic area: All drugs in Pain Management / Addiction Medicine
Indication: Drugs for Opioid use disorder maintenance treatment
Indication: Drugs for Moderate to severe pain
Also known as: OX219, Zubsolv

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing